CRITISCH Registry Assesses First-Line Treatment Strategies for CLI in Germany

July 21, 2015—To address a relevant gap in evidence on the optimal treatment strategy for critical limb ischemia (CLI), an analysis of the prospective, multicenter CRITISCH registry was undertaken to assess the current practice of all first-line treatments strategies for CLI patients in German vascular centers. The study by Theodosios Bisdas, MD, et al is available online ahead of print in the Journal of Vascular Surgery.

As summarized in the Journal of Vascular Surgery, five first-line treatment strategies—endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation—were used among CLI patients in 27 vascular tertiary centers in Germany between January 2013 and September 2014. The study included 1,200 consecutive patients.

The main composite endpoint was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used in a multivariate logistic model.

The investigators found that the first-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite endpoint was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment. The highest rate of in-hospital death was observed after primary amputation (10%) and hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rates were 8%, 14%, 6%, 5%, and 3% in each group, respectively. 

In the multivariate regression model, coronary artery disease and previous myocardial infarction (MI) within 6 months were identified as risk factors for the composite endpoint. Risk factors for amputation were dialysis and previous MI. Risk factors for death were BS compared with ER, renal insufficiency without dialysis, and previous MI, reported the investigators in the Journal of Vascular Surgery.